Standard Operating Procedure of Emulsifier in Pharmaceuticals is describe in this post.
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1 PURPOSE
1.1 To describe procedures for Emulsifier
2 SCOPE
2.1 It is applicable for Emulsifier
3 RESPONSIBILITIES
3.1 It is responsibility of Operator to follow this SOP as written, review and update as necessary
3.2 It is responsibility of the Production Manager to make certain that this SOP is followed in its entirety
3.3 It is responsibility of the Production Pharmacist to make certain that this SOP is followed in its entirety
4 PRECAUTIONS
4.1 Emulsifying head must run in material, because the rotate speed is high, if not run in material longer than 30s, it may damage the sealing system because local overheating.
4.2 The cap cannot lift too high, please push-stop when approach the limit height
4.3 Ground wire should be ground connected
4.4 It must power off before doing any maintain and cleaning progress.
4.5 It is prohibition to let hands in emulsifying pot and oil & water tank to touch any part when the machine works
4.6 Please stop immediately when have usual noise, and checks the problems
5 PROCEDURE:
5.1 Start plug in power
5.2 Add material in oil and water tank
5.3 Close the cap of oil and water tank
5.4 Heat and stir the material in oil and water tank
5.5 Close the cap of main pot, close all valves on the cap and open the vacuum valve
5.6 Heat the main pot (temperature adjustable)
5.7 Emulsify and mix the material (Stop heating when time reach the settled time )
5.8 Open the discharge valve to outlet the end product
5.9 Lift the cap after cleaning the pots
5.10 Do as the front step
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